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Trial - NCT05293236


Column Value
Trial registration number NCT05293236
Full text link
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05293236

First author
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

David Segarra

Contact
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

d.segarra@aptatargets.com

Registration date
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

2022-03-24

Recruitment status
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Sequential assignment

Masking
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

inclusion criteria: men or women with age ≥18 and ≤85 years. in case of women of childbearing potential (wocbp), they should confirm menstrual period and a negative highly sensitive urine or serum pregnancy test to be included. laboratory-confirmed sars-cov-2 infection. informed consent obtained . hypoxia (spo2<95%). documented lung opacities/infiltrates. confirmed hyperinflammation.

Exclusion criteria
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

onset of symptoms of covid-19 >14 days. pregnant or nursing (lactating) women. hospitalized >10 days for covid-19. need of high concentration non-rebreather mask, high-flow nasal cannula , non-invasive mechanical ventilation or invasive mechanical ventilation. systolic blood pressure < 90 mmhg. serious concomitant illness. recent treatment with cell-depleting therapies. enrolled in another clinical trial. severe renal dysfunction. in the opinion of the investigator, unable to comply with the requirements to participate in the study.

Number of arms
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Macarena Hernández Jiménez

Inclusion age min
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

85

Countries
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Spain

Type of patients
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

30

primary outcome
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Incidence of Adverse Events as assessed by MedDRA;Incidence of Death;Number of patients with treatment-related alterations coagulation parameters;Number of patients with treatment-related alterations Complement Factors

Notes
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "0,05 mg/kg", "treatment_id": 2408, "treatment_name": "Aptoll", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "0,1 mg/kg", "treatment_id": 2408, "treatment_name": "Aptoll", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "0,2 mg/kg", "treatment_id": 2408, "treatment_name": "Aptoll", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]